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The vRad™ PACS software is used with general purpose computing hardware, which meets or exceeds minimum specifications. vRad™ PACS software is intended to receive, transmit, store and display images for clinical purposes. The vRad™ PACS Viewer component is intended for installation on an off-the-shelf PC, meeting or exceeding minimum specifications and networked with vRad™ PACS Storage component. The vRad™ PACS Viewer is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. The vRad™ PACS Viewer can process medical images from DICOM modalities such as X-ray radiography, X-ray computed tomography, magnetic resonance imaging, ultrasound, nuclear medicine, and images from other DICOM compliant modalities.

The vRad™ PACS system should not be used for Mammography primary image diagnosis.

vRad™ PACS is a device which consists solely of software and allows electronic transmission of radiological patient images from one location to another. The device has the capability to accept, transfer, display, store, and digitally process medical images to trained and qualified radiologists for the purposes of providing digital diaging The software provides functions for performing operations interpretation services. related to image manipulation, enhancement, compression, and quantification of medical images (except mammography images). The software enables the user to display 3D maximum intensity projection (MIP) and Multi-Planar Reformatting (MPR) visualization of study images.

The provided text describes a 510(k) summary for the vRad™ Picture Archiving and Communications System (PACS) Software. However, it does not include information about specific acceptance criteria or a study that proves the device meets such criteria.

The document is a regulatory submission for a device, not a report on its performance against specific acceptance criteria. It focuses on demonstrating substantial equivalence to predicate devices based on design, technical requirements, and intended use, which is the core of a 510(k) submission.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document does not describe performance metrics, sample sizes for test or training sets, expert qualifications, adjudication methods, or results of comparative effectiveness studies or standalone performance studies.

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